Vanderbilt-Ingram Cancer Center

Participants are being asked to take part in this research study because they have cancer of the esophagus (esophageal adenocarcinoma). A standard treatment for esophageal adenocarcinoma is treatment with radiation therapy and the chemotherapy drugs paclitaxel and carboplatin. Afterwards surgery is done to remove the cancer by removing the esophagus. This study will test whether the addition of the drug trastuzumab to standard treatment with paclitaxel, carboplatin, and surgery can help prevent cancer from growing back. Trastuzumab is a drug that can only be effective in cancers that are HER2 positive. HER2 positive cancer means that the cancer has increased amounts of either HER2 genes or HER2 protein. (Genes are inside cells and make proteins.) Trastuzumab attaches to the HER2 protein. In patients with HER2 positive breast cancer, trastuzumab is proven to reduce cancer from growing back. However, the use of trastuzumab for esophageal cancer is investigational. Investigational means that the drug is not approved by the Food and Drug Administration (FDA). This study is being done to compare the effects, good and/or bad, of the addition of trastuzumab to standard chemotherapy, radiation, and surgery for patients with HER2 positive esophageal cancer. This study is being conducted by the Radiation Therapy Oncology Group (RTOG). RTOG is a group of researchers at different sites that conduct research for the National Cancer Institute (NCI). Study doctors is a member of RTOG or another group participating in the study. About 480 patients across all sites will have their esophageal cancer tissue tested to see if it is HER2 positive. It is expected that about 1 in 3 patients have esophageal cancer that is HER2 positive and therefore, about 160 patients with HER2 positive cancer will take part in the treatment portion of the study. About 14 people will take part in the study at Vanderbilt.